The required sample size in this kind of design depends heavily on the choice of the inferiority margin, with decreasing values leading to a steep increase in the sample size. It also depends to some extend on the baseline 3 year LRC and TOX rates. These were selected based on the published results from the IAEA-ACC trial. Thus, the target sample size is 836 patients. The primary analysis will be performed for all randomized patients using the intention-to-treat principle.